Affinity Fusion™
Oxygenator CB811 Fusion Cortiva US
1manufacturer
7catalogue numbers in this listing
16510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K183490 |
| Record published | 2020-01-21 |
| Record revised | 2026-02-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 30 to 75 % RH; Handling environment temperature up to 40 °C; Special storage condition: Store the product at room temperature. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB811 | In distribution | |
| BB811 | In distribution | |
| CB811 | In distribution | |
| BB811 | In distribution | |
| BB811 | In distribution | |
| CB841 | In distribution | |
| CB811 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
| Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. | Terumo Cardiovascular Systems Corporation | 6 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241352 | 2024-06-12 |
| K230640 | 2023-04-06 |
| K203111 | 2021-09-16 |
| K191444 | 2019-09-27 |
| K191029 | 2019-05-17 |
| K183490 | 2019-04-12 |
| K183511 | 2019-03-18 |
| K172984 | 2017-11-20 |
| K172626 | 2017-10-25 |
| K162896 | 2016-12-06 |
| K162016 | 2016-09-21 |
| K143073 | 2015-03-25 |
| K142784 | 2014-10-24 |
| K123314 | 2013-01-22 |
| K122827 | 2012-12-14 |
| K100645 | 2012-09-14 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | 510(k) number | 2022-12-12 | Class II | Process change control | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling | 2,937 units | |
| Medtronic Perfusion Systems | 510(k) number | 2022-12-12 | Class II | Process change control | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling | 90,220 units | |
| Medtronic Perfusion Systems | 510(k) number | 2022-12-12 | Class II | Process change control | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling | 1,340 units | |
| Medtronic Perfusion Systems | 510(k) number | 2022-12-12 | Class II | Process change control | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling | 4,462 units | |
| Medtronic Perfusion Systems | 510(k) number | 2022-12-12 | Class II | Process change control | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling | 63,278 units | |
| Medtronic Perfusion Systems | 510(k) number | 2022-12-12 | Class II | Process change control | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling | 40,498 units | |
| Medtronic, Inc. | 510(k) number | 2016-11-16 | Class II | Process control | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiot | 5609 (663 US; 4946 OUS) | 2017-08-01 |
| Medtronic Perfusion Systems | 510(k) number | 2014-10-31 | Class II | Process control | Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand | 66, UPDATE: 168 additional devices. | 2015-08-11 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-17 | Class II | Process control | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. | 217 | 2014-02-04 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 106 | 2014-05-22 |
| 2008-10-17 | Not classified | Error in labeling | Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect “Recommended maximum blood flow | 408 | 2011-04-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.